肌钙蛋白I测定试剂盒(胶乳增强免疫比浊法)-京药监械(准)字2012第2400256号-器械数据

产品名称：

肌钙蛋白I测定试剂盒(胶乳增强免疫比浊法)

注册人名称：

北京九强生物技术股份有限公司

注册(备案)号：

京药监械(准)字2012第2400256号

注册人住所：

北京市海淀区花园东路15号旷怡大厦5层

批准(备案)日期：

2012-03-02

有效期至：

2016-03-05

变更情况：

本文件与“京药监械(准)字2012第2400256号”注册证共同使用。;规格型号:R1:2X20 ml、R2:1X20 ml;R1:2X50ml、R2: 1X50m;R1: 4X50ml、R2: 2X50m;R1:2X15ml、R2: 2X15ml;R1: 2X50ml、R2: 2X50ml;R1:3X20ml、R2:1X20 ml;R1:3X60 ml、R2:3X20 ml;R1:1X60 ml、R2:1X20 ml;R1:3X20 ml、R2:1X15 ml;R1:3X60 ml、R2:3X15 ml

生产地址：

北京市怀柔区雁栖经济开发区雁栖北二街15号

型号规格：

R1:2×20ml、R2:1×20ml;R1:2×50ml、R2:1×50m;R1:4×50ml、R2:2×50m;R1:2×15ml、R2:2×15ml;R1:2×50ml、R2:2×50ml;R1:3×20ml、R2:1×20ml;R1:3×60ml、R2:3×20ml;R1:1×60ml、R2:1×20ml;R1:3×20ml、R2:1×15ml;R1:3×60ml、R2:3×15ml;R1:3×20ml、R2:1

主要组成成分：

R1:甘氨酸缓冲液;R2:乳胶颗粒超敏化的肌钙蛋白I抗体液;校准品(液体,人血清基质):肌钙蛋白I;质控品(液体,人血清基质):肌钙蛋白I